Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0203125674; N0199129912; N0176115690
Study information
Scientific title
A randomised trial of the effect of bleb site on eye comfort following trabeculectomy
Acronym
Study hypothesis
To investigate long-term post-operative eye discomfort following glaucoma surgery; in particular whether two different wound locations and therefore eye fluid drainage, differ in the level of eye comfort experienced as measured by a validated questionnaire, the 'Glaucoma Symptom Scale'.
On 14/07/2011 the following changes were made to this trial record:
1. The end date was changed from 31/12/2008 to 30/06/2010.
2. The target number of participants was changed from 40 to 150.
3. The trial was originally a multi-centre trial but due to recruitment issues at other centres the Oxford site proceeded single-handedly.
Ethics approval
Oxford Research Ethics Committee B, 10/09/2002, ref: C02.200
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Surgery: Trabeculectomy
Intervention
The study design is a randomised trial designed to compare two accepted variations in surgical techniques of trabeculectomy and its effect on postoperative eye comfort. Patients who are undergoing first trabeculectomy will be approached to participate in the study. Patients will either be recruited in person or by invitation letter. When the patient gives written consent, they are randomised either to superior trabeculectomy or superonasal trabeculectomy. At the pre-operative visit they will answer a 10-question self-administered questionnaire, the Glaucoma Symptom Scale. Some pre-operative data will be collected on study forms identified only by hospital number and study number.
During the trabeculectomy, the bleb will be placed below the middle upper lid, or placed below the more inner upper lid.
After the trabeculectomy, usual medical care will take place uninfluenced by their participation in this study. At the 6-month post-operative visit, the patient will be examined for the study and a second Glaucoma Symptom Scale questionnaire will be completed by the patient. The examination will record clinical findings such as visual acuity, eye pressure and eye examination findings. The study ends here and patients continue their usual care.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measures
1. Eye comfort at 6 months post-surgery as measured by the Glaucoma Symptom Scale
2. Eye features associated with eye discomfort (dysesthesia) at 6 months post-surgery
Secondary outcome measures
No secondary outcome measures
Overall trial start date
10/09/2002
Overall trial end date
30/06/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 18 years and over, either sex
2. Listed for trabeculectomy
3. Satisfy the inclusion criteria
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
10/09/2002
Recruitment end date
30/06/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Royal Devon and Exeter NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Royal Berkshire and Battle Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Oxford Radcliffe Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary